Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

Phase 3

Completed

• Conditions: Hepatitis B

• Registration Number: NCT02697474
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine.

Primary objectives:

* To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® \[Group 1\] or Infanrix® hexa \[Group 2\])

* To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination).

Secondary objectives:

* To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.

Detailed Description

Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and have completed the A3L12 study will be invited to participate in this study. They will receive one dose of Euvax-B® vaccine at Day 0.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-03
• Primary Completion: 2016-06
• Study Completion: 2017-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Informed consent form signed by subject's parent/legally acceptable representative
• Assent form signed by subject
• Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
• Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth.

Exclusion Criteria

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial
• Incomplete primary immunization in the A3L12 study
• Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
• Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine [OPV] in the context of oral polio vaccine-national immunization days [OPV-NIDs] does not fall within the scope of this exclusion criterion)
• Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
• Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
• Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease)
• Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
• Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine	Day 28 (post-vaccination)
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study	Day 0 (pre-vaccination)

Secondary Outcome Measures

Name	Time	Method
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study	Day 0 up to Day 28 post-vaccination